Implantable systems, devices and related methods

ABSTRACT

The present application is generally directed to implantable systems, devices and related methods pertaining to spinal surgery. In particular, the present application discloses a frame and spacer system for inserting into a disc space. The frame and spacer system is of low profile. The frame can receive different fixation devices, including threaded and non-threaded fixation devices.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 16/115,865 which is a continuation of U.S. patent applicationSer. No. 14/933,540, field Jan. 14, 2016, which is acontinuation-in-part application of U.S. patent application Ser. No.14/842,881, filed Sep. 2, 2015, now U.S. Pat. No. 10,034,768, which arehereby incorporated by reference in their entireties for all purposes.

FIELD OF THE INVENTION

The present application is generally directed to implantable systems,devices and related methods pertaining to the spine.

BACKGROUND

Spinal fusion procedures are performed on patients to treat back paincaused by degenerated discs. During spinal fusion procedures, a surgeonrestores a disc space back to its original height before inserting aninterbody fusion device. Graft material can be deposited within theinterbody fusion device to promote fusion and bone growth. There is thusa need for improved systems and devices for promoting fusion of thespine.

SUMMARY OF THE INVENTION

The present application is generally directed in some embodiments to asurgical system comprising a frame, wherein the frame comprises a firstside, a second side, a third side, and a fourth side that form acontinuous perimeter around a frame opening; a spacer received in theframe opening, wherein the spacer comprises a first arm and a second armthat extend around a spacer opening; and one or more fixation membersinsertable in the frame, wherein the one or more fixation membersincludes at least a first fixation member that is angled in an upwarddirection and a second fixation member that is angled in a downwarddirection.

In other embodiments, a surgical system comprises a frame, wherein theframe comprises a leading end, a trailing end, a first sidewall, and asecond sidewall that form a continuous perimeter around a frame opening;a spacer received in the frame opening, wherein the spacer comprises afirst arm and a second arm that extend around a spacer opening; and oneor more fixation members insertable in the trailing end of the frame,wherein the one or more fixation members includes at least a firstfixation member that is angled in an upward direction and a secondfixation member that is angled in a downward direction.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a top perspective view of a frame and spacer system inaccordance with some embodiments.

FIG. 2 shows a side view of the frame and spacer system of FIG. 1 .

FIG. 3 shows a top view of the frame and spacer system of FIG. 1 .

FIG. 4 shows a top perspective view of a frame with fixation members inaccordance with some embodiments.

FIG. 5 is a side view of the frame of FIG. 4 .

FIG. 6 is a top view of a frame and spacer system without an upperfixation member in accordance with some embodiments.

FIG. 7 is a top view of a frame and spacer system without fixationmembers in accordance with some embodiments.

FIG. 8 is a top view of a frame in accordance with some embodiments.

FIG. 9 is a side view of the frame of FIG. 8 .

FIG. 10 is a top perspective view of a frame and spacer system havingalternative fixation members in accordance with some embodiments.

FIG. 11 is a side view of the frame and spacer system of FIG. 10 .

FIG. 12 is a top perspective view of a frame with alternative fixationmembers in accordance with some embodiments.

FIG. 13 is a side view of the frame of FIG. 12 .

FIG. 14 is an anterior view of the frame of FIG. 12 .

FIG. 15 is a top perspective view of a rectangular frame and spacersystem in accordance with some embodiments.

FIG. 16 is a top perspective view of an alternative rectangular frameand spacer system in accordance with some embodiments.

FIG. 17 is a side view of a rectangular frame and spacer system inaccordance with some embodiments.

FIG. 18 is a side view of a rectangular frame and spacer system withoutfixation members in accordance with some embodiments.

FIG. 19 is a top perspective view of a rectangular frame in accordancewith some embodiments.

FIG. 20 is a top perspective view of an alternative rectangular frame inaccordance with some embodiments.

FIG. 21 is an exploded view of a spacer in accordance with someembodiments.

FIG. 22 is a top view of a frame and spacer system, wherein the spacerhas a convex side and includes a pair of graft chambers in accordancewith some embodiments.

FIG. 23 is a top view of a frame and spacer system, wherein the spacerhas a substantially flat side and includes a pair of graft chambers inaccordance with some embodiments.

FIG. 24 is a top view of a spacer including a convex side and a pair ofgraft chambers in accordance with some embodiments.

FIG. 25 is an anterior view of the spacer of FIG. 24 .

FIG. 26 is a side view of the spacer of FIG. 24 .

FIG. 27 is a top view of a spacer including a substantially flat sideand a pair of graft chambers in accordance with some embodiments.

FIG. 28 is an anterior view of the spacer of FIG. 27 .

FIG. 29 is a side view of the spacer of FIG. 27 .

FIG. 30 is a top perspective view of an alternative frame and spacersystem in accordance with some embodiments.

FIG. 31 is a front view of the alternative frame and spacer system ofFIG. 30 .

FIG. 32 is a side view of the alternative frame and spacer system ofFIG. 30 .

FIG. 33 is a top view of the alternative frame and spacer system of FIG.30 without fixation members.

FIG. 34 is a top view of the alternative frame and spacer system of FIG.30 with fixation members.

FIG. 35 is a top perspective view of the alternative frame and spacersystem of FIG. 30 with alternative fixation members.

FIG. 36 is a side view of the alternative frame and spacer system ofFIG. 30 with alternative fixation members.

FIG. 37 is a top view of a spacer and plug in accordance with someembodiments.

FIG. 38 is an exploded view of the spacer and plug of FIG. 37 .

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

The present application is generally directed to implantable systems,devices and related methods pertaining to the spine. In particular, thepresent application is generally directed to systems and devices forinserting into a disc space of a spine to promote fusion betweenvertebrae. The systems and devices can be inserted into the spine viaany approach, such as posteriorly, transforaminally, laterally oranteriorly. In some embodiments, the systems and devices describedherein can be used at least in part as a vertebral body replacement,such that the systems and devices occupy one or more vertebral bodies inaddition or instead of one of more disc members.

In some embodiments, a frame and spacer system is provided that can beinserted into a disc space as part of a fusion procedure.Advantageously, the frame is independent from the spacer such that asurgeon can choose the type of spacer (e.g., either PEEK or allograft)to insert within the frame. In addition, if desired, the frame canadvantageously be inserted on its own as a standalone device without thespacer in between vertebrae. The frame can be dimensioned to fit betweentwo vertebrae, and can be sturdy enough to support a load from thevertebrae.

FIG. 1 shows a top perspective view of a frame and spacer system inaccordance with some embodiments. The frame and spacer system 10comprises a frame 50 having fixation members 32, 34, 36 and a spacer 80received therein. The frame and spacer system 10 is configured to beplaced in a disc space and receive graft material therein, therebypromoting spinal fusion and bone growth. In some embodiments, the frameand spacer system 10 is sized and configured such that the entire systemis of low profile. Advantageously, as the system 10 is of low profile,the frame 50 and the spacer 80 can be completely received within a discspace such that no portion of it protrudes outside of a disc space. Insome embodiments, the system 10 can be sized to replace one or morevertebral bodies, or parts thereof, in addition to one or more discmembers.

As shown in FIG. 1 , in some embodiments, the frame 50 and the spacer 80can be of substantially the same height. Advantageously, this allowsboth the frame 50 and the spacer 80 to share vertebral load. In someembodiments, the upper and lower surfaces of the frame 50 can share theoverall contour of the upper and lower surfaces of the spacer 80 andvice versa. For example, in embodiments in which the spacer 80 has aconvex upper surface and a convex lower surface, the frame 50 cansimilarly have a convex upper surface and a convex lower surface.Likewise, in embodiments in which the spacer 80 has a planar uppersurface and a planar lower surface, the frame 50 can similarly have aplanar upper surface and a planar lower surface. In other embodiments,the spacer 80 can have a height that slightly larger than the frame 50,while still maintaining an overall low profile system. In otherembodiments, the frame 50 can have a height slightly larger than thespacer 80, while still maintaining an overall low profile system.

FIG. 1 shows one type of cage or frame 50 in accordance with someembodiments. The frame 50 comprises a first side 52, a second side 54, athird side 56 and a fourth side 58. The first side 52, second side 54,third side 56 and fourth side 58 form a structure having a continuousperimeter. Advantageously, by providing a continuous perimeter thatextends around the outside of the spacer 80, the frame 50 is capable ofbearing load. As the frame 50 can bear load, the frame 50 can be used onits own as a fusion device within an intervertebral disc space. As shownin FIG. 1 , the first side 52, second side 54, third side 56 and fourthside 58 surround an opening 59. A spacer 80 (such as a PEEK or allograftspacer) can optionally be placed in the opening 59 of the frame 50 priorto inserting the frame 50 into a disc space.

With respect to the frame 50, the first side 52 opposes the second side54. In some embodiments, the first side 52 can comprise a first sidewalland the second side 54 can comprise a second sidewall. The first side 52comprises a first window 72 and the second side 54 comprises a secondwindow 74. In some embodiments, the first window 72 is configured toreceive a first bump out or protruding portion located on the spacer 80and the second window 74 is configured to receive a second bump out orprotruding portion 84 located on the spacer 80. By receiving theprotruding portions 84 of the spacer 80 in the windows 72, 74, thisadvantageously provides regions of secure engagement between the frame50 and the spacer 80. In some embodiments, to secure the frame 50 to thespacer 80, the spacer 80 can be downwardly forced into the frame 50(e.g., via hand or a press assembly) until the protruding portions 84 ofthe spacer 80 are received in the windows 72, 74. At this point theframe 50 is secured to the spacer 80 such that the two members can bedelivered securely to a disc space in preparation for bone fusion.

With respect to the frame 50, the third side 56 opposes the fourth side58. In some embodiments, the third side 56 can comprise a posterior orleading edge, while the fourth side 58 can comprise an anterior ortrailing edge. In some embodiments, the third side 56 can comprise athird window 76. In some embodiments, the third window 76 can beconfigured to receive a bump out or protruding portion on a posteriorsurface of the spacer 80. In other embodiments, the third window 76 cansimply be used to promote fusion by allowing bone growth through itduring a spinal fusion procedure.

In some embodiments, the fourth side 58 of the frame 50 can receivefixation members therein to secure the frame 50 to adjacent vertebralbodies. In some embodiments, the frame 50 comprises a first opening 62for receiving a first fixation member 32, a second opening 64 forreceiving a second fixation member 34, and a third opening 66 forreceiving a third fixation member 36. The first fixation member 32 isangled in an upward direction to engage an upper vertebra, while thesecond and third fixation members 34, 36 are angled in a downwarddirection to engage a downward vertebra. In some embodiments, the frame50 is of such a low profile that no portion of the fixation members 32,34, 36 protrudes beyond the disc space. For example, in someembodiments, the fixation members 32, 34, 36 would not enter into thevertebrae through their anterior faces. In other embodiments, only arear portion of the fixation members 32, 34, 36 (e.g., their heads)protrudes beyond the disc space. And in yet other embodiments, only asmall portion of their overall bodies (e.g., including the shaft)protrudes beyond the disc space. In these embodiments, it is possiblethat a minimal portion of the fixation members 32, 34, 36 can contactthe anterior faces of the vertebrae. In some embodiments, the frame 50is of such a low profile that each of the openings 62, 64, 66 has amajority of or all of their central longitudinal axes positioned betweenthe height of the spacer 80, as defined from an upper surface of thespacer 80 to a lower surface of the spacer 80.

To prevent inadvertent backout of the fixation members 32, 34, 36, theframe 50 further includes a first blocking member 44 and a secondblocking member 46. The first blocking member 44 includes one or morecut-out regions 45 that allow first and second fixation members 32, 34to be received in the first and second openings 62, 64. Once the firstand second fixation members 32, 34 are received therein, the firstblocking member 44 can be rotated such that a portion of the firstblocking member 44 overlies the heads of the each of the first andsecond fixation members 32, 34, thereby reducing the likelihood ofbackout of the fixation members. Likewise, the second blocking member 46includes one or more cut-out regions 47 that allow second and thirdfixation members 34, 36 to be received in the second and third openings64, 66. Once the second and third fixation members 34, 36 are receivedtherein, the second blocking member 46 can be rotated such that aportion of the second blocking member 46 overlies the heads of the eachof the first and second fixation members 32, 34, thereby reducing thelikelihood of backout of the fixation members. In some embodiments, thefirst and second blocking members 44, 46 do not overlie the heads of thefixation members, but rather about the sides of the heads of thefixation members. Each of the first and second blocking members 44, 46can be considered “multi-blocking” members, as they block two or morefixation members from backing out. In other embodiments, each of theopenings 62, 64, 66 includes its own individual blocking member toreduce the risk of backout of the fixation member.

As shown in FIG. 1 , the fixation members 32, 34, 36 comprise threadedscrews or fasteners. The screws can include a head portion and athreaded shaft. In some embodiments, the threaded shaft can be taperedto assist in insertion into vertebrae. In other embodiments, differentfixation members 32, 34, 36 can be provided. For example, as shown inFIGS. 10-14 , non-threaded blades or shims can be inserted into thevertebrae. Advantageously, these alternative fixation members can beinserted into frame via the same openings 62, 64, 66, thereby allowing auser to choose the type of fixation member to use. In some embodiments,the same fixation members (e.g., threaded screws or non-threaded blades)are insertable through the frame 50. In other embodiments, a combinationof different types of fixation members (e.g., one threaded screw and twonon-threaded blades) are insertable through the frame 50.

The fourth side of the frame 50 can also include first and second toolengagement holes 68. As shown in FIG. 1 , one hole 68 is positioned on afirst side of the frame 50, while a second hole 68 is positioned on asecond side of the frame 50. Each of these holes 68 can be engaged by aninsertion tool to facilitate easy delivery of the system 10 into a discspace.

The frame 50 of the system 10 also includes an upper surface 51 and alower surface 53. The upper surface 51 is configured to engage an uppervertebra, while the lower surface 53 is configured to engage a lowervertebra. In some embodiments, the upper surface 51 and the lowersurface 53 can include teeth, protrusions, ribbing or ridges 55 thatassist in engagement with an adjacent vertebra.

In some embodiments, the frame 50 can be formed of a metal or metalalloy. In some embodiments, the frame 50 can be formed of titanium,titanium alloy, steel, steel alloy or any other biocompatible material.In some embodiments, the frame 50 is of a different material from thespacer 80 that resides within it. For example, the frame 50 can beformed of titanium, while the spacer 80 can be formed of PEEK orallograft.

FIG. 1 shows one type of spacer 80 in accordance with some embodiments.The spacer 80 is designed to reside in the opening 59 formed in theframe 50. Advantageously, a surgeon can choose the type of spacer 80(e.g., either PEEK or allograft) to insert into the frame 50, evenimmediately before a surgical procedure. In some embodiments, a surgeonmay desire to promote greater bone growth, thereby choosing an allograftspacer 80. In other embodiments, a surgeon may desire to promote greaterstructural strength, thereby choosing a PEEK spacer 80.

As shown in FIG. 1 , the spacer 80 comprises a C-shaped spacer having anupper surface 81 and an opposing lower surface. The upper and lowersurfaces are configured to include teeth, protrusions, ribbing, orridges 85 that engage adjacent vertebral bodies. The spacer 80 caninclude an opening 87 formed therethrough in which graft material can bedeposited therein. The graft material can be deposited to promote fusionand bone growth. In some embodiments, a plug (e.g., a cancellous plug)can be deposited in the opening 87. In some embodiments, demineralizedbone can be deposited in the opening 87 to further promote fusion andbone growth.

In some embodiments, the spacer 80 can comprise a multi-piece spacerthat can be formed of a first member 82 joined to a second member 84 (asshown in FIG. 3 ). Each of the members 82, 84 can include a protrudingportion 84 that can be received in a corresponding window of the frame50. The first member 82 and the second member 84 can be joined togethervia an adhesive, pins, or other attachment means, thereby forming theC-shaped member. In the C-shaped spacer, the first member 82 forms afirst arm of the C-shaped spacer while the second member 84 forms asecond arm of the C-shaped spacer. By providing a multi-piece spacer,the spacer 80 is capable of having a large footprint, which isparticularly useful for patients having large anatomies and disc spaces.In some embodiments, the spacer 80 can be formed of more than twomembers, such as three, four, five or more members that are attached toone another to form a unitary spacer 80.

FIG. 2 shows a side view of the frame and spacer system of FIG. 1 . Fromthis view, one can see the shape of the frame 50 in accordance with someembodiments. The frame 50 includes an upper chamfer 61 and a lowerchamfer 63 that forms a tapered leading end. Advantageously, the upperchamfer 61 and the lower chamfer 63 can aid in distraction and/orinsertion of the frame 50 into a disc space. In addition, from thisview, the upper surface of the frame 50 appears substantially parallelto the lower surface of the frame 50. However, in some embodiments, oneor both of the upper surface and/or lower surface can be curved (e.g.,convex). From this view, one can also see the second window 74 and thethird window 76 that are formed through different surfaces of the frame50. As shown in the figure, the spacer 80 includes a protruding portion84 that is received in the second window 74, thereby securing the frame50 to the spacer 80.

FIG. 3 shows a top view of the frame and spacer system of FIG. 1 . Thespacer 80 is nested in the opening 59 of the frame 50. The spacer 80 isformed of a first member 82 and a second member 84 attached to oneanother at an interface 86 to form a C-shaped implant. The two members82, 84 surround a spacer opening 87 through which a plug or graftmaterial can be deposited therein. In some embodiments, a plug such as acancellous plug (as shown in FIGS. 22 and 23 ) can be deposited in thespacer opening 87. As shown in FIG. 3 , the spacer 80 can comprise of aconvex leading end and a concave trailing end. The spacer 80 cancomprise an upper chamfer and a lower chamfer. In some embodiments, theupper chamfer and lower chamfer of the spacer 80 substantially match theupper and lower chamfer of the frame 50.

From this view, one can also see the overall shape of the frame 50. Thefirst side 52 and second side 54 of the frame 50 can be curved. Thethird side 56, or leading side, of the frame 50 can also be curved. Thefourth side 58, or trailing side, of the frame 50 can be flat or curvedin accordance with some embodiments. As shown in FIG. 3 , the fourthside 58, which houses the fixation members and blocking members, has agreater thickness than the third side 56.

FIG. 4 shows a top perspective view of a frame with fixation members inaccordance with some embodiments, while FIG. 5 is a side view of thesame frame. The frame 50 can advantageously be used as a standalonedevice that is operable on its own without a spacer 80. From this view,one can see how the frame 50 includes a first window 72, a second window74 and a third window 76. One or more of the windows can permit graftmaterial to extend therethrough, thereby promoting fusion in a discspace.

FIG. 6 is a top view of a frame and spacer system without an upperfixation member in accordance with some embodiments. With the upper orfirst fixation member 32 removed, one can see how the first opening 62extends through the fourth side 58 of the frame 50. As shown in FIG. 6 ,the first opening 62 begins and extends through an anterior surface ofthe fourth side 58 of the frame 50, and exits through an edge of aposterior surface of the fourth side 58 of the frame 50.

FIG. 7 is a top view of a frame and spacer system without fixationmembers in accordance with some embodiments. With the upper or firstfixation member 32 removed, one can see how the first opening 62 extendsthrough the fourth side 58 of the frame 50. As shown in FIG. 7 , thefirst opening 62 begins and extends through an anterior surface of thefourth side 58 of the frame 50, and exits through an edge of a posteriorsurface of the fourth side 58 of the frame 50.

FIG. 8 is a top view of a frame, while FIG. 9 is a side view of theframe, in accordance with some embodiments. The frame 50 is shownwithout a spacer 80 or any of the fixation elements. The frame 50includes a convex anterior or leading end, as well as a slightly convexposterior or trailing end. The anterior end has an upper chamfer 61 anda lower chamfer 63 (shown in FIG. 2 ). The frame 50 includes a number ofsurface protrusions, teeth, ribbing or ridges 55 that provide engagementsurfaces with adjacent vertebrae. As shown in FIG. 8 , portions of theupper and/or lower chamfered surfaces of the spacer 80 do not includeridges 55.

FIG. 10 is a top perspective view of a frame and spacer system havingalternative fixation members in accordance with some embodiments. Theframe and spacer system 110 shares many similar features as in priorembodiments, including a frame 50 for receiving fixation members and aspacer 80 received therein. A first fixation member 132, a secondfixation member 134, and a third fixation member 136 are receivedthrough the frame 50. However, in the present embodiment, each of thefixation members 132, 134, 136 are blades or shims. Advantageously, thefixation members 132, 134, 136 can be non-threaded such that they areeasily inserted into bone, thereby saving time.

FIG. 11 is a side view of the frame and spacer system of FIG. 10 . Fromthis view, one can see the first fixation member 132 and the thirdfixation member 136, which are non-threaded. In addition, one can seehow the spacer 80 is retained in the frame 50 via one or more bump outsor protruding portions 84.

FIG. 12 is a top perspective view of a frame with alternative fixationmembers in accordance with some embodiments, while FIG. 13 is a sideview. The frame 50 can be a standalone frame that can be used on its ownwithout a spacer. In some embodiments, the frame 50 has a height thatenables it to support a load, and is configured to receive one or morefixation members 132, 134, 136 to secure the frame 50 to vertebralbodies.

FIG. 14 is an anterior view of the frame of FIG. 12 . As shown in thefigure, the frame 50 includes an upper surface 102 and a lower surface104. In some embodiments, the upper surface 102 is convex. In someembodiments, the lower surface 104 is convex. From this view, one canalso see how the first blocking member 44 and the second blocking member46 cover the upper heads of the fixation members 132, 134, 136 to reducethe likelihood of backout of the fixation members. Each of the blockingmembers 44, 46 resides in a recess that is formed adjacent a pair ofopenings. Each of the blocking members 44, 46 thus serves as amulti-block device, capable of reducing the risk of backout of twofixation members.

FIG. 15 is a top perspective view of a rectangular frame and spacersystem in accordance with some embodiments. The system 210 includes arectangular cage or frame 250 that receives a spacer 280 therein.

The frame 250 comprises a first side 252, a second side 254, a thirdside 256, and a fourth side 258. The sides 252, 254, 256, 258 form acontinuous perimeter for receiving a spacer 280 therein. First side 252opposes the second side 254, while third side 256 opposes the fourthside 258. In some embodiments, the third side 256 can be considered aposterior or leading end, while the fourth side 258 can be considered ananterior or trailing end. As shown in FIG. 15 , the fourth side 258includes a first opening 62 for receiving a first fixation member 32, asecond opening 64 for receiving a second fixation member 34 and a thirdopening 66 for receiving a third fixation member 36. In the presentembodiment, the fixation members 32, 34, 36 are all threaded screws,while in other embodiments, one or more of the fixation members can benon-threaded blades or shims.

As in prior embodiments, frame includes one or more windows 74 which canserve one or more functions. In some embodiments, the windows 72, 74(shown in FIG. 20 ) can be used to receive graft material therethrough.In addition, the windows 72, 74 can be used to retain one or more bumpout or protruding portions of the spacer 280, thereby helping to securethe spacer 280 with the frame 250.

Additionally, in some embodiments, the frame 250 includes one or moreprotrusions or nubs 294 (shown in FIG. 20 ) that can also be used tosecure the frame 250 to the spacer 280. As shown in FIG. 15 , the spacer280 can include one or more grooves or notches 284 formed along asidewall that can receive the one or more nubs 294 therein.Advantageously, in some embodiments, the combination of the one or morenubs 294 and the one or more notches 284 forms a tight friction orinterference fit, thereby securing the frame 250 to the spacer 280. Inthe present embodiment, the frame 250 includes a single nub 294 formedalong an inner wall of its third side 256. However, in other embodiment,the frame 250 can include one, two, three or more nubs 294 formed ondifferent inner walls.

The spacer 280 is configured to be received within an opening 259 in theframe 250. As in prior embodiments, the spacer 280 can be formed of PEEKor allograft, as desired by the surgeon. The spacer 280 is configured toinclude an opening 287 therein. In some embodiments, graft material isreceived in the opening 287. In other embodiments, a plug can bereceived in the opening 287. The spacer 280 can be formed of one, two,three, four or more members that are assembled0 together via an adhesiveor mechanical connection assembly. In the present embodiment, the spacer280 has an overall rectangular profile that is configured tosubstantially match the contour of the frame 250.

As shown in FIG. 15 , the spacer 280 includes one or more grooves ornotches 284 for receiving one or more nubs 294 of the frame 250. The oneor more notches 284 advantageously help to secure the frame 250 to thespacer 280. The notches 284 can be formed vertically along an outer wallof the spacer 280. For example, in the embodiment in FIG. 15 , the notch284 is formed on an outer wall of the spacer 280 that is adjacent theleading or third side of the frame 250. In other embodiments, the frame250 can include one or more notches, while the spacer 280 includes oneor more nubs, thereby creating a friction fit between the two members.

FIG. 16 is a top perspective view of an alternative rectangular frameand spacer system in accordance with some embodiments. The frame andspacer system 210 has many similar features to that shown in FIG. 15 ,including a top surface 251 and a bottom surface 253, and four wallsthat provide a continuous perimeter around a spacer. However, in thepresent embodiment, the frame 250 includes at least one side includingmultiple windows 74 in the form of a lattice 274. By providing thewindows in the form of a lattice 274, this advantageously providesmultiple sites of possible bone growth along the side of the frame 250.

FIG. 17 is a side view of a rectangular frame and spacer system inaccordance with some embodiments, while FIG. 18 is a side view of arectangular frame and spacer system without fixation members inaccordance with some embodiments. From these views, one can see how thespacer 280 is received in the frame 250. As shown in the figures, thespacer 280 can have a height that is the same as or less than the heightof the frame 250. Also, from these views, one can see how the frame 250includes ridges 55 that protrude upwardly from its surface to assist inengagement with bone. The frame 250 includes an upper chamfer 261 and alower chamfer 263.

FIG. 19 is a top perspective view of a rectangular frame in accordancewith some embodiments, while FIG. 20 is a top perspective view of analternative rectangular frame in accordance with some embodiments. As inprior embodiments, the frame 250 can be a standalone frame wherein itcan be inserted into a disc space without including a spacer if desired.

FIG. 21 is an exploded view of a spacer in accordance with someembodiments. As shown in FIG. 21 , the spacer 380 can be a multi-piecespacer formed of different members that are connected together via oneor more connection mechanisms (e.g., pins). The spacer 380 can be formedof any suitable biocompatible material, including metal, PEEK or bone.In particular, spacers 380 that are formed of bone (e.g., allograft) maybenefit from being formed of multiple members, as this allows spacersare greater sizes to be formed. The spacer 380 includes an upper surfaceand a lower surface including surface texturing, protrusions, teeth orridges 355 formed thereon.

In FIG. 21 , the spacer 380 includes a first member 382, a second member384 and a third member 386. When the members 382, 384, 386 are joinedtogether, they form a C-shaped spacer 380, similar to that shown in FIG.1 . In some embodiments, each of the members 382, 384, 386 includes achamfered upper surface and a chamfered lower surface, such that whenthe members are joined, the spacer 380 includes an upper chamfer and alower chamfer. For example, as shown in FIG. 21 , the spacer 380 willinclude an upper chamfer 387.

As shown in FIG. 21 , the different members 382, 384, 386 of the spacer380 can be secured together via one or more pin members 391. In someembodiments, the one or more pin members 391 can be formed of a similarmaterial as one or more members 382, 384, 386 of the spacer 380. In someembodiments, one or more members 382, 384, 386 of the spacer 380 can beformed of allograft bone, and one or more pin members 391 can also beformed of allograft bone. In some embodiments, the one or more pinmembers 391 are formed at an angle other than parallel or 90 degreesrelative to an interface formed between two members. In addition, insome embodiments, the one or more pin members 391 are received in blindpin holes, whereby at least one side of the pin holes is not exposed oropen. In other embodiments, the one or more pin members 391 are receivedin non-blind pin holes. While in FIG. 21 , the different members 382,384, 386 are positioned horizontally to one another, in otherembodiments, the different members can be stacked and connectedvertically to one another.

FIG. 22 is a top view of a frame and spacer system, wherein the spacerhas a convex side and includes a pair of graft chambers in accordancewith some embodiments. In the present embodiment, the system comprises aframe 50 and a spacer 480 that is received within the frame 50.Advantageously, the spacer 480 is in the form of an E-shape, such thatit has a first chamber 497 and a second chamber 499. The chambers 497,499 are separated by a strut 420 formed on the frame 50. Advantageously,both the first chamber 497 and the second chamber 499 are capable ofreceiving a plug 444 therein, as shown in FIG. 22 . In some embodiments,one or more of the plugs 444 is formed of bone (e.g., cortical orcancellous) and assists in fusion. In some embodiments, one or more ofthe plugs 444 includes bone fibers. In some embodiments, one or more ofthe plugs 444 is demineralized. By providing a pair of chambers 497, 499for receiving bone-growth material therein, this advantageouslyincreases the area for promoting bone-growth material. In addition, itallows for multiple smaller pieces of bone growth material (e.g., twoplugs) to be used, as opposed to fewer larger pieces of bone growthmaterial, which can be difficult to source.

FIG. 23 is a top view of a frame and spacer system, wherein the spacerhas a substantially flat side and includes a pair of graft chambers inaccordance with some embodiments. The spacer 580 is similar to thespacer 480 in that it includes a first chamber 497 independent from asecond chamber 499. The overall shape of the spacer 580, however, ismore like a rectangle, such that it is designed to fit within asubstantially rectangular region of a frame.

FIG. 24 is a top view of a spacer including a convex side and a pair ofgraft chambers in accordance with some embodiments. The spacer 480 is anE-shaped spacer having a first chamber 497 and a second chamber 499. Thespacer 480 includes a convex outer wall 495. In the present embodiment,the spacer 480 is formed of four members: a first member 482, a secondmember 484, a third member 486 and a fourth member 488.

FIG. 25 is an anterior view of the spacer of FIG. 24 . From this view,one can see how the spacer 480 includes a convex upper surface 481 and aconvex lower surface 483. Accordingly, the spacer 480 can advantageouslyhave convexity in multiple planes, thereby accommodating differentanatomical features. In some embodiments, the spacer 480 has convexityin at least two planes: an X-Y plane (as shown in FIG. 24 ) and an X-Zplane (as shown in FIG. 25 ). The spacer 480 can be considered biconvexin two planes.

FIG. 26 is a side view of the spacer of FIG. 24 . From this view, onecan see how the spacer 480 includes an upper surface 481, an opposinglower surface 483, an upper chamfer 489 and a lower chamfer 491. In someembodiments, the spacer can be in the form of a wedge member that isable to self-distract between two vertebrae in preparation forperforming a fusion procedure.

FIG. 27 is a top view of a spacer including a substantially flat sideand a pair of graft chambers in accordance with some embodiments. Thespacer 580 is an E-shaped spacer having a first chamber 597 and a secondchamber 599. The spacer 580 includes a slightly curved outer wall 595.In the present embodiment, the spacer 580 is formed of three members: afirst member 582, a second member 584, and a third member 586.

FIG. 28 is an anterior view of the spacer of FIG. 27 . From this view,one can see how the spacer 580 includes a convex upper surface 581 and aconvex lower surface 583. Accordingly, the spacer 580 can advantageouslyhave convexity in multiple planes, thereby accommodating differentanatomical features. In some embodiments, the spacer 580 has curvaturein at least two planes: an X-Y plane (as shown in FIG. 27 ) and an X-Zplane (as shown in FIG. 28 ).

FIG. 29 is a side view of the spacer of FIG. 27 . From this view, onecan see how the spacer 580 includes an upper surface 581, an opposinglower surface 583, an upper chamfer 589 and a lower chamfer 591. In someembodiments, the spacer can be in the form of a wedge member that isable to self-distract between two vertebrae in preparation forperforming a fusion procedure.

Methods of using the systems and devices are now provided. In someembodiments, a disc space is formed between a first vertebra and asecond vertebra. A frame and spacer system 10, such as shown in FIG. 1 ,can be prepared to be delivered to the disc space. A surgeon can choosethe type of spacer 80 to attach to the frame 50, and can then attach theelements together via a press mechanism. The spacer 80 can be retainedin the frame 50 via bump out or protruding portions 84. The frame andspacer system 10 (without fixation members) can be attached to aninsertion tool via its first and second tool engagement holes 68. Theframe and spacer system 10 can then be delivered via the tool into thedisc space, such as via an anterior approach. The frame and spacersystem 10 is of a low profile such that it is positioned completelywithin the disc space. Optional graft material could be packed withinthe frame and spacer system 10 prior to delivery. Once the frame andspacer system 10 is positioned within the disc space, one or morefixation members 32, 34, 36 can be delivered to secure the frame 50 andspacer 80 to the first and second vertebrae. The frame and spacer system10 can be left in the surgical site, whereby it will be used to promotefusion and bone growth.

In alternative embodiments, a standalone frame 50, as shown in FIG. 4 ,can be prepared to be delivered to the disc space. The standalone frame50 can be delivered to the disc space without a spacer 80. The frame 50(without fixation members) can be attached to an insertion tool via itsfirst and second tool engagement holes 68. The frame 50 can then bedelivered via the tool into the disc space, such as via an anteriorapproach. The frame 50 is of a low profile such that it is positionedcompletely within the disc space. Optional graft material could bepacked within the frame 50 prior to delivery. Once the frame 50 ispositioned within the disc space, one or more fixation members 32, 34,36 can be delivered to secure the frame 50 to the first and secondvertebrae. The standalone frame 50 can be left in the surgical site,whereby it will be used to promote fusion and bone growth.

FIG. 30 is a top perspective view of an alternative frame and spacersystem in accordance with some embodiments. The frame and spacer system610 includes similar features as in prior embodiments, including a frame650, a spacer 680, a first fixation member 632, a second fixation member634 and a third fixation member 636. The frame 650 comprises an uppersurface 651 and a lower surface 653, each of which is designed to engagea vertebral member. The frame 650 includes an opening 659 for receivingthe spacer 680 therein. Moreover, the frame 650 includes openings forreceiving fixation members 632, 634, 636 therein. To prevent back out ofthe fixation members 632, 634, 636, a first blocking member 644 and asecond blocking member 646 can be provided. In addition to thesefeatures, the frame and spacer system 610 has distinct geometricalfeatures that advantageously allow it to be of low profile and to betteraccommodate a patient's anatomy.

FIG. 31 is a front view of the alternative frame and spacer system ofFIG. 30 . From this view, one can see a front or anterior view of theframe 650. The frame 650 includes a distinct upper surface 660 that isadvantageously designed to be low profile. In particular, the uppersurface 660 comprises an arched portion 664 positioned between twoadjacent slanted portions 662 a, 662 b. The slanted portions 662 a, 662b have a height that is reduced relative to the arched portion 664,thereby enhancing the low profile of the frame 650. In some embodiments,the frame 650 can also include a lower surface of a similar shape to theupper surface 660 to thereby reduce the overall profile of the frame andspacer system 610.

FIG. 32 is a side view of the alternative frame and spacer system ofFIG. 30 . From the side view, one can see the first fixation member 632that is angled upwardly and the third fixation member 636 which isangled downwardly.

FIG. 33 is a top view of the alternative frame and spacer system of FIG.30 without fixation members, while FIG. 34 is a top view of thealternative frame and spacer system with fixation members. As shown inthe figure, the frame 650 comprises a first side 652, a second side 654,a third side 656 and a fourth side 658. The frame 650 advantageouslyencompasses a spacer 680 having a first side 682, a second side 684 anda third side 686. As shown in FIG. 33 , in some embodiments, the frame650 and the spacer 680 include a distinct shape and form that provides abetter anatomical fit with certain patients. With respect to the frame650, the first side 652 and the second side 654 comprise convexly curvedsurfaces, while the third side 656 comprises a concave surface. Thespacer 680, which follows the contour of the frame 650, also has a firstside 682 and second side 684 that comprise convexly curved surfaces anda third side 686 that comprises a concavely curved surface.

FIG. 35 is a top perspective view of the alternative frame and spacersystem of FIG. 30 with alternative fixation members, while FIG. 36 is aside view of the same system. The frame and spacer system 610 comprisesa frame 650 and a spacer 680 with non-threaded blades or shims 732, 734,736 received through the frame 650.

FIG. 37 is a top view of a spacer and plug in accordance with someembodiments. The spacer 680 and plug 690 can advantageously be used withany of the frames (such as frame 650) shown above. In some embodiments,the spacer 680 is formed of PEEK or allograft. In the presentembodiment, the spacer 680 is formed of allograft bone and is formed ofmultiple members assembled together (as shown in FIG. 38 ). In someembodiments, the plug 690 is formed of a natural material, such as bone(e.g., cancellous bone). The advantage of providing such a plug 690 isthat it helps to promote enhanced fusion.

FIG. 38 is an exploded view of the spacer and plug of FIG. 37 . As shownin the figure, the spacer 680 is formed of a first member 682, a secondmember 684 and a third member 686 held together via pins 688 a, 688 b,688 c, 688 d. In some embodiments, the pins 688 a, 688 b, 688 c, 688 dare also formed of bone. A first pair of pins 688 a, 688 b is receivedthrough the interface between the members 682, 686, while a second pairof pins 688 c, 688 d is received through the interface between themembers 684, 686.

The systems described above can be used with a number of differentsurgical implants. Among the surgical implants include stabilizationimplants, including plates, screws (e.g., pedicle screws) and rods. Inaddition, more than one frame and spacer system can be applied, such asto different levels of the spine. In addition, the frame and spacersystems described above can be used with different prosthetic devices,such as facet devices.

It will be apparent to those skilled in the art that variousmodifications and variations can be made in the present inventionwithout departing from the scope or spirit of the invention. Moreover,the frame and spacer systems described above need not feature all of theobjects, advantages, features and aspects discussed above. Thus, forexample, those skilled in the art will recognize that the invention canbe embodied or carried out in a manner that achieves or optimizes oneadvantage or a group of advantages as taught herein without necessarilyachieving other objects or advantages as may be taught or suggestedherein. In addition, while a number of variations of the invention havebeen shown and described in detail, other modifications and methods ofuse, which are within the scope of this invention, will be readilyapparent to those of skill in the art based upon this disclosure. It iscontemplated that various combinations or subcombinations of thesespecific features and aspects of embodiments may be made and still fallwithin the scope of the invention. Accordingly, it should be understoodthat various features and aspects of the disclosed embodiments can becombined with or substituted for one another in order to form varyingmodes of the discussed bone screw assemblies. Thus, it is intended thatthe present invention cover the modifications and variations of thisinvention provided that they come within the scope of the appendedclaims or their equivalents.

What is claimed is:
 1. A surgical system comprising: a spacer having ac-shape with a first arm terminating at a first free end, a second armterminating at a second free end, the first and second arms each havingan outer surface, a portion of each outer surface being convexly curvedand a portion of each outer surface being concavely curved; a framehaving an upper surface and a lower surface, a first inner surface, asecond inner surface, a third inner surface, and a fourth inner surfacethat form a continuous perimeter around a frame opening, and an outersurface comprising a first window, a second window, and a plurality ofopenings formed therethrough; wherein the spacer is received in theframe opening such that the frame extends around an outside of thespacer and the first, second, third, and fourth inner surfaces of theframe correspondingly engage with at least a portion of the outersurfaces of the first and second arms of the spacer; and a plurality offixation members each insertable in one of the plurality of openings inthe outer surface of the frame, wherein one of the fixation members isangled in an upward direction and one of the fixation members is angledin a downward direction.
 2. The surgical system of claim 1, wherein atleast a portion of the outer surface of the frame is convex.
 3. Thesurgical system of claim 1, wherein at least one of the plurality offixation members is a non-threaded blade.
 4. The surgical system ofclaim 1, wherein the spacer further comprises a first protruding portionand a second protruding portion, wherein the first protruding portion isconfigured to be received in the first window and the second protrudingportion is configured to be received in the second window.
 5. Thesurgical system of claim 1, wherein the frame further comprises an upperchamfer and a lower chamfer.
 6. The surgical system of claim 1, whereinthe plurality of openings in the outer surface of the frame includes afirst opening, a second opening and a third opening, wherein the firstopening is configured to receive a first one of the fixation members,the second opening is configured to receive a second one of the fixationmembers, and the third opening is configured to receive a third one ofthe fixation members.
 7. The surgical system of claim 1, wherein thespacer is formed of allograft bone.
 8. The surgical system of claim 1,wherein the spacer is formed of multiple members secured to one anothervia pin members.
 9. The surgical system of claim 1, wherein the spaceris configured to receive a cancellous plug therein.
 10. A surgicalsystem comprising: a c-shaped spacer having a first arm terminating at afirst free end, a second arm terminating at a second free end, the firstand second arms each having an outer surface, a portion of each outersurface being convexly curved and a portion of each outer surface beingconcavely curved; a frame having a leading end, a trailing end, an uppersurface and a lower surface, a first inner surface, a second innersurface, a third inner surface, and a fourth inner surface that form acontinuous perimeter around a frame opening, and an outer surfacecomprising a first window, a second window, and a plurality of openingsformed therethrough, wherein the plurality of openings are formed in thetrailing end of the frame; wherein the spacer is received in the frameopening such that the first, second, third, and fourth inner surfaces ofthe frame correspondingly engage with at least a portion of the outersurfaces of the first and second arms of the spacer; and a plurality offixation members each insertable in one of the plurality of openings inthe trailing end of the frame, wherein one of the fixation members isangled in an upward direction and one of the fixation members is angledin a downward direction.
 11. The surgical system of claim 10, whereinthe leading end of the frame is convex.
 12. The surgical system of claim10, wherein the spacer is biconvex in two planes.
 13. The surgicalsystem of claim 10, wherein the plurality of openings in the trailingend of the frame includes a first opening for receiving a first one ofthe fixation members, a second opening for receiving a secondnon-threaded one of the fixation members, and a third opening forreceiving a third non-threaded one of the fixation members.
 14. Thesurgical system of claim 10, wherein the frame and the spacer havesubstantially the same height.